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EMA's CHMP recommends approval of Suliqua

Nov. 14, 2016

Ultragenyx Pharmaceutical withdraws conditional MAA from the EMA for Ace-ER

Nov. 14, 2016

EMA gives positive opinion on Gilead's MAA for Vemlidy

Nov. 14, 2016

EMA adopts positive opinion for Novo Nordisk's Fiasp

Nov. 14, 2016

EMA committee hands down positive opinion on Arzerra for relapsed CLL

Nov. 14, 2016

Eloxx Pharmaceuticals reports orphan drug designations for ELX-02 from both FDA and EMA

Nov. 9, 2016

EMA accepts MAA from Celltrion for CT-P6

Nov. 7, 2016

Bio-Path Holdings' BP-1001 awarded orphan drug status from EMA

Nov. 4, 2016

FDA and EMA accept Novartis' applications for ribociclib plus letrozole in advanced breast cancer

Nov. 2, 2016

EMA accepts PharmaMar's MAA for plitidepsin

Oct. 31, 2016

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